Clinical trial · Interventional
Imaging of Advanced Tumours Using [131]I-IAZA
A Radiopharmacokinetic and Radiodosimetric Phase I/II Imaging Study of 1-alpha-D-(5-[131I]Iodo-5-deoxyarabinofuranosyl)-2-Nitroimidazole (131I-IAZA) in Patients With Locally Advanced or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Abandoned.
Summary
Brief summary (as posted)
Hypoxic cells in tumors have less oxygen than normal cells do, which leads to several changes inside the cells that lead to genetic chages making these cells resistant to treatment. The end result of this is increased tumor growth, spread of the tumor and poor outcome. Early studies have shown that \[131\]I-IAZA scans can help detect if there are hypoxic cells in the tumor. A \[131\]I-IAZA scan is a nuclear medicine test used to create pictures of the whole body after \[131\]I-IAZA is injected into a vein. Further scientific research will help understand how \[131\]I-IAZA is distributed throughout the body and how it can be used to treat hypoxic tumor cells. The purpose of this study is to : 1. Demonstrate the safety of \[131\]I-IAZA 2. To Determine the biodistribution and tumor avidity of \[131\]I-IAZA in patients with locally advanced or metastatic solid tumors. 3. To determine the optimal imaging time of \[131\]I-IAZA SPECT. 4. To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of \[131\]I-IAZA. 5. To determine whole body dosimetry of \[131\]I-IAZA in selected patients. 6. To evaluate tumor dosimetry of \[131\]I-IAZA in patients with positive uptake. 7. To determine the radiation dose accrued in hypoxic tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [131]I-IAZA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [131]I-IAZA whole body and SPECT imaging
- description
- Injection of a single dose of 185MBq ( range 150-220MBq) of \[131\]I-IAZA prior to whole body imaging acquisition at 0-1 hrs,1-3 hrs , 4-8 hrs,19-36 hrs,41-72 hrs and 6-8 days post-injection. SPECT CT of target lesion(s) will be acquired at 19-36 hrs post injection.
- interventionNames
- Drug: [131]I-IAZA
Primary outcomes (4)
- measure
- Change in vital signs after [131]I-IAZA injection (first 10 patients)
- timeFrame
- Up to 36 hours post-injection
- description
- Vital signs are measured before injection of \[131\]I-IAZA and after the third and fourth scans
- measure
- Change in hematology/SMA-12 serum biochemistry after [131]I-IAZA injection (first 10 patients)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥18 and ≤ 75 years of age; * Subjects with locally advanced or metastatic solid tumors with at least one lesion evaluable by CT or magnetic resonance imaging (MRI) of at least 1 cm (smallest diameter), as measured by Response Evaluation Criteria In Solid Tumors (RECIST) within 12 weeks of enrolment; * Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase) ≤ 5 times the upper limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment; * Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 3 x 109/L; platelets ≥ 75 x 109/L measured within 2 weeks of enrolment. * Serum creatinine ≤ 150 µmol/L, and a calculated (Cockcroft-Gault) or estimated glomerular filtration rate (GFR) of ≥ 50 mL/min measured within 2 weeks of enrolment. * Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment; * Able and willing to follow instructions and comply with the protocol; * Ability to provide written informed consent prior to participation in the study. Exclusion Criteria: * Systemic therapy for tumors within 2 weeks; * Prior external beam radiation therapy to the only evaluable lesion * Existing tracheostomy * Pregnant or breast feeding * Previously negative 18F-FAZA uptake of only evaluable lesion(s) within 3 months of enrolment. * Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.) * Inability to complete the needed investigational examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation .
References
Publications (0)
Data not yet available